Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis

Phase 3

• Conditions: Acute Cholecystitis; Empyema
• Interventions: Procedure: Surgical drainage

• Registration Number: NCT01625247
• Lead Sponsor: Yonsei University

Brief Summary

Laparoscopic cholecystectomy (LC) is the current preferred method of cholecystectomy. The role of routine drainage after LC to decrease postoperative morbidity is still an issue of considerable debate. The goal of this study was to assess to role of drains in LC, performed for acute inflamed gallbladder.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Status Verified: 2012-06
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-20
• Last Update Submitted: 2012-06-20
• Study First Posted: 2012-06-21
• Last Update Posted: 2012-06-21
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• Acute cholecystis
• Laparoscopic cholecystectomy
• KAROFSKY PERFORMANCE SCALE > 70
• No history of major operation

Exclusion Criteria

• NYHA class > 3
• Open cholecystectomy
• No- compliance
• Intraoperative injuries
• Inadequate hemostasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 arm	Surgical drainage	Patients under LC. Allocated to drain placement . Drainage was removed if the drainage amount was less than 20cc.
2 arm	Surgical drainage	Patients under LC. Allocation to sham drain,

Primary Outcome Measures

Name	Time	Method
frequency of postoperative complication occurrence	whinin 1 week and 8 weeks postoperatively

Trial Locations

Locations (1)

Gangnam Severance hospital; 🇰🇷 Seoul, Korea, Republic of